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The real-world safety of sacubitril / valsartan among older adults (≥75): A pharmacovigilance study from the FDA data.

Authors :
Lerman TT
Greenberg N
Fishman B
Goldman A
Talmor-Barkan Y
Bauer M
Goldberg I
Goldberg E
Kornowski R
Krause I
Levi A
Cohen E
Source :
International journal of cardiology [Int J Cardiol] 2024 Feb 15; Vol. 397, pp. 131613. Date of Electronic Publication: 2023 Nov 27.
Publication Year :
2024

Abstract

Background: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population.<br />Methods: We conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction.<br />Results: The FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59-77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: P <subscript>interaction</subscript>  = 0.72, hyperkalemia: P <subscript>interaction</subscript>  = 0.94, hypotension: P <subscript>interaction</subscript>  = 0.31, and angioedema: P <subscript>interaction</subscript>  = 0.61).<br />Conclusions: In this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults.<br /> (Copyright © 2023 Elsevier B.V. All rights reserved.)

Details

Language :
English
ISSN :
1874-1754
Volume :
397
Database :
MEDLINE
Journal :
International journal of cardiology
Publication Type :
Academic Journal
Accession number :
38030039
Full Text :
https://doi.org/10.1016/j.ijcard.2023.131613